The SmartPen Advanced EDC System
The SmartPen combines the convenience of paper with the speed and accuracy of EDC to provide continuous collection of trial data and performance metrics. This gives you continuous, real-time information for tighter trial management and more informed decision-making. Proven in studies around the world and 21 CFR part 11-compliant, the SmartPen also cuts down on the clerical workload at sites and drastically reduces query rates and overall monitoring costs.
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Ease the burden on your sites to make your trial run better and faster.
In a typical Web EDC system, paper case report forms (CRFs) are filled out, and then data needs to be manually keyed into the system through a computer. When sites get busy, these paper source documents can pile up for days or weeks before the data ever makes it into the system. With the SmartPen, doctors and nurses at sites fill out the paper form once, and the information is automatically transmitted to the HD360° system - eliminating a time-consuming step in the process as well as the error-prone keyboard entry, making better data available as soon as possible. And, the SmartPen simplifies source-data verification because the pen transmits an exact digital copy of the CRF to the Health Decisions data management team, eliminating tedious faxing of forms. This process also helps reduce queries because data managers can easily compare the digital source document with the data to avoid much of the time-consuming back-and-forth with the sites, and drastically reduce monitoring costs. |
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